Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022

The primary duty bearers are health practitioners who choose to supply a biological under the authorisation. Only those listed in column 5 of the Schedule are authorised to supply directly to their own patients under subsection 5(1). For example, only an orthopaedic surgeon may supply Ortho-ATI cell suspension, and only a medical practitioner (any registered medical practitioner) may supply Amniotic Membrane or Tutoplast Pericardium. The instrument also affects a second class of health practitioners: those who supply a biological to a patient of another treating practitioner (the treating practitioner). That second supplier may be any health practitioner, because the rules do not restrict them by type; the authorisation flows from the request of the treating practitioner who is specified in the Schedule. Indirectly, the instrument affects patients who receive these unapproved biologicals. They are entitled to be informed that the product is not on the Register and must give informed consent. They also have no recourse under the usual TGA pre-market safety net, though they may have rights under tort law if harmed. The instrument also affects sponsors of these biologicals indirectly: the authorisation allows supply without a registered sponsor, but the existing sponsorship provisions of the Act still apply if the product is imported or manufactured by a sponsor. The instrument does not alter the obligations of manufacturers or importers under other parts of the Act. Regulators at the TGA are affected because they must receive and process adverse event and defect reports within 15 days, and they must maintain the Schedule. The instrument may also affect professional indemnity insurers, who may re-assess risk for practitioners supplying unapproved products, and public hospitals or day surgeries where such biologicals are administered, because their policies on unregistered products may conflict or require internal approvals.

The instrument imposes several duties on the health practitioner who supplies the biological. Under subsection 5(2), where the practitioner supplies directly to his or her own patient, the practitioner must: (a) inform the patient (or a parent or guardian) that the biological is not included in the Register; (b) obtain informed consent before supply; (c) supply in accordance with good medical practice or the relevant code of conduct; (d) notify the TGA of any adverse event within 15 days of becoming aware; and (e) notify the TGA of any defect in the biological within 15 days of becoming aware. For a practitioner supplying at the request of a treating practitioner (subsection 5(4)), the duties are narrower: only adverse event reporting and defect reporting apply. The treating practitioner who requests the supply does not have a direct reporting duty under this instrument, but would still be subject to professional obligations. The right of the patient is to be informed and to give or withhold consent. However, there is no right to access the biological: the practitioner is authorised to supply but is not required to do so. The patient has no right under this instrument to demand a particular unapproved biological. The instrument does not create a private right of action for breach of its conditions; enforcement is through the Act. The reporting duty is significant: it applies to any adverse event, not only those believed to be caused by the product. The definition of adverse event is broad enough to capture coincidental events, which imposes a compliance burden. The 15-day timeline is tight compared to post-market surveillance for registered products. The duty to report defects is also broad: a defect may include manufacturing issues, packaging defects, or quality problems. Practitioners must have systems in place to identify such defects and report them quickly.

The instrument itself does not prescribe penalties. It operates by modifying the prohibition in section 32CM of the Act. If a practitioner supplies a biological in a way that does not satisfy all conditions of the authorisation, the supply is unauthorised and becomes unlawful. That means the general penalties under the Act for supplying an unregistered biological would apply. Under section 32CM of the Therapeutic Goods Act 1989, the maximum penalty for supplying a biological that is not included in the Register is 10 years imprisonment and/or a fine of up to 5,000 penalty units (currently $1,100 per unit, so $5.5 million) for an individual, and significantly higher for a body corporate. Therefore, the compliance risk is severe. The reporting duties are not directly penalised by this instrument, but failure to report an adverse event or defect could be evidence that the supply did not meet the condition of “good medical practice” or the code of conduct, potentially rendering the supply unauthorised. Alternatively, the Act contains offences for failing to provide information to the TGA, though the instrument does not incorporate those. The TGA can also take administrative action, such as suspending or cancelling the inclusion of a biological in the Schedule, or issuing public safety warnings. The burden of proof in any prosecution would be on the prosecution to show that a condition was not met. Since the instrument uses terms like “in accordance with good medical practice”, there may be significant litigation risk around what that standard requires in the context of an unapproved biological. The instrument does not create any infringement notice provisions or civil penalty regime specific to these rules.

This instrument sits within the broader framework of the Therapeutic Goods Act 1989, particularly Part 3-2, Division 3 (biologicals). The Act generally prohibits supply of a biological unless it is included in the ARTG or an exemption applies. Subsection 32CM(7A) empowers the Minister (delegated to make legislative instruments, hence these Rules) to authorise supply of a biological that is not included in the Register. The Rules operate as an exemption to that prohibition. They do not override other Commonwealth laws, such as the Competition and Consumer Act 2010 (including the Australian Consumer Law) which imposes consumer guarantees and product safety provisions. A patient harmed by an unapproved biological may still sue for breach of warranty, negligence, or under the ACL. The instrument does not affect state and territory health practitioner regulation, including professional codes of conduct, scope of practice, and mandatory reporting requirements. The condition in subsection 5(2)(c) that supply be in accordance with “good medical practice or the relevant code of conduct” directly incorporates those professional standards. A practitioner who supplies outside their scope of practice (e.g., a medical practitioner supplying an orthopaedic biological not listed for medical practitioners) would be in breach of state law as well as the instrument. The instrument also interacts with privacy laws: reporting adverse events and defects to the TGA involves disclosing patient information, which must be done in compliance with the Privacy Act 1988 and any state health records legislation. The instrument does not provide an express authorisation to breach privacy; the reporting duty would likely be justified under the permitted health situation exception in APP 6. Additionally, the instrument does not address import, manufacturing, or labelling requirements under the Act. If the biological is imported, it must still comply with Customs and quarantine requirements. If it is manufactured in Australia, Good Manufacturing Practice (GMP) licences may still be required under other provisions of the Act, even if supply is authorised under these Rules. The instrument only authorises supply; it does not authorise manufacture or import that would otherwise be unlawful.

The source provided does not contain any amendment history. The instrument was made in 2022 (its title is Therapeutic Goods (Biologicals,Authorised Supply) Rules 2022). Without access to the Federal Register of Legislation or other sources, we cannot determine whether it has been amended since commencement. The user’s instruction is to ground every claim in the source. Therefore, we can only note that the instrument itself does not contain any amending provisions or a section on amendments. The Schedule may have been modified subsequent to the original instrument, because the explanatory statement or authority for making the rules may allow the Minister to add or remove biologicals by amending the Schedule without remaking the entire instrument. However, the user’s source does not reveal any such amendments. For the purposes of this deep dive, we must state that the source shows the instrument in its originally enacted form, with three listed items in the Schedule, and no indication of any later changes. Practitioners and advisors should check the current version on the Federal Register of Legislation to confirm whether any biologicals have been added, removed, or varied, and whether the conditions or authorisation provisions have been altered. The fact that the instrument is a legislative instrument means it is subject to parliamentary tabling and may be disallowed, but the source does not indicate any disallowance motion.

The source does not mention any litigation. Because the instrument is relatively new (2022) and deals with a narrow access pathway for unapproved biologicals, there is unlikely to be reported case law directly about these Rules. However, there is a body of case law under the Therapeutic Goods Act generally concerning the meaning of “supply”, “biological”, and “adverse event”. Any litigation about the Rules would likely arise in two contexts: prosecution for alleged unauthorised supply (where the accused argues they fell within the authorisation), or civil claims for personal injury from a patient against a practitioner or sponsor. In the latter case, the court would likely consider whether the practitioner complied with the conditions, especially informed consent and good medical practice. The instrument would be relevant evidence of the standard of care - if the practitioner failed to inform the patient that the biological was unregistered, that could constitute negligence per se. There is also potential for judicial review of a decision by the Secretary or Minister to include or exclude a biological from the Schedule, or to remove a product. No such cases are reported yet. The absence of litigation history does not mean the instrument is risk-free; it may simply indicate that the pathway is little used, or that disputes are being resolved without public judgments. Practitioners should assume that any breach of the conditions will attract scrutiny, and that compliance with the instrument does not immunise them from negligence claims. The disclosure requirement is particularly fertile ground for litigation if a patient later suffers an adverse outcome and claims they were not adequately informed of the risks of an unapproved product.

Several features of the instrument may catch practitioners off guard. First, the reporting duty for adverse events applies to any adverse event, not just those suspected to be related. The note to section 4 explicitly states that an adverse event may not necessarily have a causal relationship. That means a patient who falls and breaks a leg the day after receiving the biological must still be reported, unless the practitioner is unaware of it. The 15-day clock starts from when the practitioner becomes aware, which could be days or weeks later, but failure to report could be used to argue that the supply was not in accordance with the conditions. Second, the condition in subsection 5(2)(c) to supply “in accordance with good medical practice or the relevant code of conduct” is open-ended. A practitioner who supplies a biological for an indication not listed, or who fails to properly screen the patient, may be found to have breached this condition, making the supply unauthorised. The instrument does not define “good medical practice”, leaving it to professional standards bodies and courts. Third, the informed consent requirement may be more onerous than usual because the biological is unregistered. The practitioner must specifically inform the patient that the product is not on the Register. That may imply that it has not been assessed for safety, quality, or efficacy. A generic consent form may not suffice; the disclosure must be specific. Fourth, the instrument is silent on who bears the cost of the biological and of any follow-up for adverse events. If the product must be imported or custom-manufactured, the costs may be high, and if adverse events occur, the practitioner may be personally liable for management. Fifth, the Schedule may change without public notice; practitioners should check the current version each time they intend to supply. Sixth, the definition of “supply” in the Act is broad and includes distribution, storage, and perhaps even prescribing. A practitioner who merely prescribes a biological for a patient to obtain from a pharmacy or manufacturer may be engaging in supply, which would require authorisation under these Rules. Seventh, the instrument does not impose any record-keeping requirement beyond what would be considered good medical practice, but the lack of explicit record-keeping obligations may lead to gaps in evidence if a dispute arises. Finally, the authorisation only applies to the specific biological named. There is no “similar” catch-all. A practitioner cannot supply a different brand or variant of the same type of cell therapy just because it is analogous.

A health practitioner wishing to supply an unapproved biological under these Rules must first confirm that the product, route, indication, and practitioner type match an item in Schedule 1. The source shows only three items, but the full current Schedule should be consulted at the Federal Register of Legislation. The practitioner should verify that the biological being supplied is exactly the product described in column 2. For example, “Amniotic Membrane” is generic, but the practitioner should ensure it is the same product that the TGA considered when listing the item. The practitioner should then ensure that all conditions in subsection 5(2) (if supplying directly to their own patient) or subsection 5(3)-(4) (if supplying for a treating practitioner) are satisfied. In practice, compliance requires:

• Pre-supply steps: Develop a patient information sheet that clearly states the biological is not registered on the ARTG. Obtain written, signed informed consent after a discussion of known risks, uncertainties, and alternative treatments. For paediatric or incapacitated patients, involve a parent or guardian. Ensure that the supply is for the precise indication listed. For example, Ortho-ATI is only for chronic lateral epicondylitis or gluteal tendinopathy of more than six months not responsive to conservative treatment, with or without partial tear. Using it for acute injury or other tendinopathies would be outside the authorisation.

• Supply itself: The route must match exactly (ophthalmic, intratendinous injection, topical). The practitioner must supply in accordance with good medical practice, meaning they must have appropriate facilities, training, and infection control. For surgical implantation (Tutoplast as a soft tissue graft), the graft must be used in a clinical setting consistent with that product’s intended use and instructions for use (if available). Keep records of the product batch number, expiry, and supply date.

• Post-supply monitoring: The practitioner must establish a system to detect adverse events and defects. This could involve asking patients to report any health changes, reviewing medical records, and staying alert to product complaints. If an adverse event or defect is discovered, notify the TGA within 15 calendar days. The notification should be made using the TGA’s adverse event reporting system (SUSMP or other). The practitioner should also document all steps taken to comply with the conditions, as this will be vital if the TGA investigates.

• Ongoing: Check the Schedule periodically for updates, removals, or new conditions. Maintain professional indemnity insurance that covers supply of unapproved products. If supplying as a secondary practitioner (subsection 5(3)), obtain a written request from the treating practitioner and keep it on file, as the treating practitioner is the one responsible for the indication and suitability of the patient. The secondary supplier still has reporting duties but need not independently verify consent or the patient-practitioner relationship.

• Risk management: Consider whether institutional approvals are needed (e.g., from a hospital’s drug and therapeutics committee). If the biological is imported, ensure the importer holds any required licence under the Act, as these Rules do not authorise import. For cells sourced from a donor (e.g., amniotic membrane), ensure compliance with the Therapeutic Goods Order for donor screening. The practitioner should not assume that listing in Schedule 1 means the product has been assessed for safety; the listing is merely an administrative act. Therefore, the practitioner should conduct their own risk-benefit analysis for each patient and document it.